Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache

Headache Clinical Trial

Official title:

Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00752921
• Other study ID #: 54661.ctil
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 15, 2008
• Last updated: September 15, 2008
• Start date: September 2008
• Est. completion date: October 2008

Study information

• Verified date: September 2008
• Source: Shaare Zedek Medical Center
• Contact: Zev S Wimpfheimer, MD
• Phone: 972 50 868 5466
• Email: zevw[@]hotmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Headache during fasting is a known entity in the scientific literature. The prevalence of such a headache is high and in a study conducted in Israel was found in 60% of people with a previous predilection for headache. A prior study showed a significant decrease in the incidence of fasting headache using rofecoxib, but the drug has been taken off the market. The goal of this project is to evaluate the efficacy of etoricoxib as treatment taken before the fast- a COX-2 inhibitor with a relatively long half life to prevent fasting induced headache. The study will be a prospective double blind placebo controlled trial using adult volunteers with a history of a fasting headache who will be abstaining from food and drink on Yom Kippur.

The study hypothesis is that treatment with etoricoxib prior to a 25 hour fast will decrease the incidence of fasting headache.

Description:

Fasting is a known trigger for headache. More specifically, headache associated with ritual fasting in compliance with religious edict has been documented and described in the literature. These have been described in Jewish and Muslim ritual fasts, and have been dubbed 'Yom Kippur headache,' and 'First of Ramadan headache' respectively. The incidence of fasting associated headache during the 25 hour fast of Yom Kippur (YK) wherein no food or drink is ingested, has been documented in approximately 40% of participants, but as high as 66% of those prone to headache. (1) A recent study was published in which the authors were able to show a marked reduction in YK headache using rofecoxib 50mg, a Cox 2 specific nonsteroidal anti-inflammatory medication with a relatively long (17 hour) half life. In a placebo controlled double blind randomized trial, in a population with a history of fasting headache, the drug was ingested just prior to the start of the fast. The placebo group had an incidence of headache 65% of the time whereas the treatment group had an incidence of 19%. Headache in the treatment set was also on average milder than in the controls. These results were all significant statistically. (3)

Unfortunately for sufferers of fasting headache, rofecoxib (Vioxx), has been removed from the market and is no longer available.

We therefore propose to conduct a second study using etoricoxib (Arcoxia) - a Cox 2 specific antiinflammatory medication with a longer half life than rofecoxib.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age 18 -65.

• Patients will be enrolled if they declared that they intended to complete the 25 hour YK fast, and had demonstrated their commitment by doing so for the previous three years (unless medically prevented.)

• We will only enroll patients who stated that they typically suffered from headache during the fast.

Exclusion Criteria:

• Patients with chronic medical problems including:

• Heart disease,

• Kidney disease,

• Liver disease,

• Peptic ulcer disease,

• Hypertension,

• Diabetes,

• Lung disease including asthma,

• History of gastrointestinal bleeding,

• Patients with allergies or intolerance in the past to NSAIDs,

• Pregnancy or lactation.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Headache

Intervention

Drug:
• etoricoxib
120 mg
• placebo
placebo

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Awada A, al Jumah M. The first-of-Ramadan headache. Headache. 1999 Jul-Aug;39(7):490-3. — View Citation

Drescher MJ, Elstein Y. Prophylactic COX 2 inhibitor: an end to the Yom Kippur headache. Headache. 2006 Nov-Dec;46(10):1487-91. — View Citation

Mosek A, Korczyn AD. Yom Kippur headache. Neurology. 1995 Nov;45(11):1953-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Fasting Headache		25 hours after administration	No